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NCT03004443 · ClinicalTrials.gov registry record · Phase 4
Inflammation-Induced CNS Glutamate Changes in Depression
A Phase 4 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT03004443: Clinical Trial Phase 4 study, sponsored by Emory University.
NCT03004443 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03004443, a Phase 4 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
Increased inflammation has been implicated in the pathophysiology of a number of neuropsychiatric illnesses including mood disorders, which affect almost 30 million adults in the United States alone. One mechanism by which inflammation may alter behavior is through increasing brain glutamate, a neurotransmitter that in excess has been implicated in neuronal toxicity and resistance to conventional antidepressant therapy. The goal of the proposed research is to test the hypothesis that inflammation alters behavior through increasing glutamate in specific brain regions, ultimately leading to behavioral changes. The proposed research is designed to determine the cause and effect relationship between inflammation and CNS glutamate as well as the relationship between CNS glutamate and specific symptoms. To accomplish these aims, investigators will administer a single infusion of either the tumor necrosis factor (TNF) antagonist infliximab or placebo (n=30 per group) to patients with high inflammation (CRP\>3mg/L). A CRP\>3mg/L was chosen because it is considered high inflammation according to guidelines by the American Heart Association. Moreover, a CRP\>3mg/L is associated with significantly increased basal ganglia glutamate and with a clinical response to infliximab. Inflammatory biomarkers, basal ganglia glutamate as measured by MRS, and motivation and psychomotor activity will be assessed at baseline and days 1 and 3 and weeks 1 and 2 following infliximab or placebo administration.
Primary Outcome
Left basal ganglia glutamate was measured by magnetic resonance spectroscopy (MRS). Left basal ganglia glutamate tends to be increased during inflammation and is also associated with an increase in depressive symptoms.
Interventions
- DRUG Placebo
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2019-11-27 |
| Phase | Phase 4 |
Why NCT03004443 stopped before completion
NCT03004443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03004443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03004443 about?
NCT03004443 is a clinical study titled "Inflammation-Induced CNS Glutamate Changes in Depression". Increased inflammation has been implicated in the pathophysiology of a number of neuropsychiatric illnesses including mood disorders, which affect almost 30 million adults in the United States alone. One mechanism by which inflammation may alter behavior is through increasing brain glutamate, a neur...
What is the current status of trial NCT03004443?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2017-05-15. Estimated completion is 2019-11-27.
What interventions are being tested in trial NCT03004443?
The interventions under investigation include: Placebo (DRUG), Infliximab (DRUG).
Who is sponsoring clinical trial NCT03004443?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03004443's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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